Received approval for a new drug, intended for the therapy of neuroendocrine tumors
Last reviewed: 23.04.2024
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The FDA, the US Food and Drug Administration, recommended the use of the Lutathera medication (Lutetia 177Lu), which is designed to treat neuroendocrine tumors in the digestive system. This kind of radiopharmaceutical medication was approved for the first time: it is planned to be used as a medicament for adult patients, with diagnosed neuroendocrine neoplasms of the digestive organs, and expression of the somatostatin receptor apparatus.
It is a question of the newest radiopharmaceutical medicine, the therapeutic effect of which is conditioned by the interrelation with the somatostatin receptor mechanism localized on the cellular structures of the tumor. At the end of binding with the receptor mechanism, the drug enters the tumor cell structures, damaging them from the inside.
The FDA recommended a new medication after evaluating the results of two research projects.
The first clinical randomized testing was conducted with the involvement of more than two hundred patients suffering from different types of neuroendocrine oncology of the digestive organs, with the expression of the somatostatin receptor apparatus. Patients were offered a combination of a new drug and octreotide, or only octreotide. The percentage of survival with subsequent positive dynamics was found in patients treated with a combination of a new drug with octreotide. Among those patients who did not take Lutathera, survival was less, and the disease continued to progress to some extent. Scientists concluded that the participants of the first group of the risk of death or further development of the tumor process was several times less, compared with the participants in the second group.
In the following experiment, more than 1200 patients participated, with diagnosed neuroendocrine neoplasms of the digestive system, with the expression of somatostatin receptors. By results, a noticeable decrease in the size of pathological formation was recorded in 16% of cancer patients.
Of course, the scientists described and possible side effects on the background of treatment with the newest drug. Among the common manifestations were recorded lymphopenia, increased content of individual enzymes (ALT, AST, GGT), dyspepsia, hypokalemia, hyperglycemia.
Among a number of serious adverse events, especially myelosuppressive conditions, the development of secondary myelodysplastic syndrome and leukemia, liver and kidney damage, reproductive harm, hormonal disorders.
Lutathera is definitely not suitable for the treatment of pregnant women. In addition, patients who are treated with a new drug are exposed to radiation. Therefore, during the therapeutic course, they will have to limit contact with other people - including relatives and medical staff. This is implied by the rules of radiation safety.
Material provided by FDA.gov
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